82 FR 34694 - Importer of Controlled Substances Application: United States Pharmacopeial Convention
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 142 (July 26, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 142 (July 26, 2017)
| Page Range | 34694-34695 | |
| FR Document | 2017-15693 |
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)] [Notices] [Pages 34694-34695] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15693] [[Page 34694]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: United States Pharmacopeial Convention ACTION: Notice of application. ----------------------------------------------------------------------- DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before August 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 25, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 15, 2017, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Cathinone........................... 1235 I Methaqualone........................ 2565 I Lysergic acid diethylamide.......... 7315 I Marihuana........................... 7360 I Tetrahydrocannabinols............... 7370 I 4-Methyl-2,5-dimethoxyamphetamine... 7395 I 3,4-Methylenedioxyamphetamine....... 7400 I 4-Methoxyamphetamine................ 7411 I Codeine-N-oxide..................... 9053 I Difenoxin........................... 9168 I Heroin.............................. 9200 I Morphine-N-oxide.................... 9307 I Normethadone........................ 9635 I Methamphetamine..................... 1105 II Phenmetrazine....................... 1631 II Methylphenidate..................... 1724 II Amobarbital......................... 2125 II Pentobarbital....................... 2270 II Secobarbital........................ 2315 II Glutethimide........................ 2550 II Phencyclidine....................... 7471 II 4-Anilino-N-phenethyl-4-piperidine 8333 II (ANPP). Phenylacetone....................... 8501 II Alphaprodine........................ 9010 II Anileridine......................... 9020 II Cocaine............................. 9041 II Dihydrocodeine...................... 9120 II Diphenoxylate....................... 9170 II Levomethorphan...................... 9210 II Levorphanol......................... 9220 II Meperidine.......................... 9230 II Dextropropoxyphene, bulk (non-dosage 9273 II forms). Thebaine............................ 9333 II Noroxymorphone...................... 9668 II Alfentanil.......................... 9737 II Sufentanil.......................... 9740 II ------------------------------------------------------------------------ The company plans to import the listed controlled substances in bulk powder form from foreign sources for the manufacture of analytical reference standards for sale to their customers. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale. [[Page 34695]] Dated: July 20, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-15693 Filed 7-25-17; 8:45 am] BILLING CODE 4410-09-P
![34694 Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
DEPARTMENT OF JUSTICE ADDRESSES: Written comments should (DEA), 28 CFR 0.100(b). Authority to
be sent to: Drug Enforcement exercise all necessary functions with
Drug Enforcement Administration Administration, Attention: DEA Federal respect to the promulgation and
Register Representative/DRW, 8701 implementation of 21 CFR part 1301,
[Docket No. DEA–392] Morrissette Drive, Springfield, Virginia incident to the registration of
22152. All requests for hearing must be manufacturers, distributors, dispensers,
Importer of Controlled Substances sent to: Drug Enforcement importers, and exporters of controlled
Application: United States Administration, Attn: Administrator, substances (other than final orders in
Pharmacopeial Convention 8701 Morrissette Drive, Springfield, connection with suspension, denial, or
Virginia 22152. All request for hearing revocation of registration) has been
ACTION: Notice of application. should also be sent to: (1) Drug redelegated to the Assistant
Enforcement Administration, Attn: Administrator of the DEA Diversion
DATES: Registered bulk manufacturers of Hearing Clerk/LJ, 8701 Morrissette Control Division (‘‘Assistant
the affected basic classes, and Drive, Springfield, Virginia 22152; and Administrator’’) pursuant to section 7 of
applicants therefore, may file written (2) Drug Enforcement Administration, 28 CFR part 0, appendix to subpart R.
comments on or objections to the Attn: DEA Federal Register In accordance with 21 CFR
issuance of the proposed registration in Representative/DRW, 8701 Morrissette 1301.34(a), this is notice that on
accordance with 21 CFR 1301.34(a) on Drive, Springfield, Virginia 22152. February 15, 2017, United States
or before August 25, 2017. Such persons SUPPLEMENTARY INFORMATION: The Pharmacopeial Convention, 12601
may also file a written request for a Attorney General has delegated his Twinbrook Parkway, Rockville,
hearing on the application pursuant to authority under the Controlled Maryland 20852 applied to be registered
21 CFR 1301.43 on or before August 25, Substances Act to the Administrator of as an importer of the following basic
2017. the Drug Enforcement Administration classes of controlled substances:
Controlled substance Drug code Schedule
Cathinone ........................................................................................................................................................................ 1235 I
Methaqualone .................................................................................................................................................................. 2565 I
Lysergic acid diethylamide .............................................................................................................................................. 7315 I
Marihuana ........................................................................................................................................................................ 7360 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
4-Methyl-2,5-dimethoxyamphetamine ............................................................................................................................. 7395 I
3,4-Methylenedioxyamphetamine .................................................................................................................................... 7400 I
4-Methoxyamphetamine .................................................................................................................................................. 7411 I
Codeine-N-oxide .............................................................................................................................................................. 9053 I
Difenoxin .......................................................................................................................................................................... 9168 I
Heroin .............................................................................................................................................................................. 9200 I
Morphine-N-oxide ............................................................................................................................................................ 9307 I
Normethadone ................................................................................................................................................................. 9635 I
Methamphetamine ........................................................................................................................................................... 1105 II
Phenmetrazine ................................................................................................................................................................. 1631 II
Methylphenidate .............................................................................................................................................................. 1724 II
Amobarbital ...................................................................................................................................................................... 2125 II
Pentobarbital .................................................................................................................................................................... 2270 II
Secobarbital ..................................................................................................................................................................... 2315 II
Glutethimide ..................................................................................................................................................................... 2550 II
Phencyclidine ................................................................................................................................................................... 7471 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II
Phenylacetone ................................................................................................................................................................. 8501 II
Alphaprodine .................................................................................................................................................................... 9010 II
Anileridine ........................................................................................................................................................................ 9020 II
Cocaine ............................................................................................................................................................................ 9041 II
Dihydrocodeine ................................................................................................................................................................ 9120 II
Diphenoxylate .................................................................................................................................................................. 9170 II
Levomethorphan .............................................................................................................................................................. 9210 II
Levorphanol ..................................................................................................................................................................... 9220 II
Meperidine ....................................................................................................................................................................... 9230 II
Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. 9273 II
Thebaine .......................................................................................................................................................................... 9333 II
Noroxymorphone ............................................................................................................................................................. 9668 II
Alfentanil .......................................................................................................................................................................... 9737 II
Sufentanil ......................................................................................................................................................................... 9740 II
mstockstill on DSK30JT082PROD with NOTICES
The company plans to import the distribution to its customers for research applications will occur only when the
listed controlled substances in bulk and analytical purposes. Placement of registrant’s business activity is
powder form from foreign sources for these drug codes onto the company’s consistent with what is authorized
the manufacture of analytical reference registration does not translate into under 21 U.S.C. 952(a)(2). Authorization
standards for sale to their customers. automatic approval of subsequent will not extend to the import of FDA
The company plans to import permit applications to import controlled approved or non-approved finished
analytical reference standards for substances. Approval of permit dosage forms for commercial sale.
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![Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices 34695
Dated: July 20, 2017. applicants therefore, may file written implementation of 21 CFR part 1301,
Demetra Ashley, comments on or objections to the incident to the registration of
Acting Assistant Administrator. issuance of the proposed registration in manufacturers, distributors, dispensers,
[FR Doc. 2017–15693 Filed 7–25–17; 8:45 am] accordance with 21 CFR 1301.33(a) on importers, and exporters of controlled
BILLING CODE 4410–09–P or before September 25, 2017. substances (other than final orders in
ADDRESSES: Written comments should connection with suspension, denial, or
be sent to: Drug Enforcement revocation of registration) has been
DEPARTMENT OF JUSTICE Administration, Attention: DEA Federal redelegated to the Assistant
Register Representative/DRW, 8701 Administrator of the DEA Diversion
Drug Enforcement Administration Morrissette Drive, Springfield, Virginia Control Division (‘‘Assistant
[Docket No. DEA–392] 22152. Administrator’’) pursuant to section 7 of
SUPPLEMENTARY INFORMATION: The 28 CFR part 0, appendix to subpart R.
Bulk Manufacturer of Controlled
Attorney General has delegated his In accordance with 21 CFR
Substances Application: AMRI
authority under the Controlled 1301.33(a), this is notice that on March
Rensselaer, Inc.
Substances Act to the Administrator of 30, 2017, AMRI Rensselaer, Inc., 33
ACTION: Notice of application. the Drug Enforcement Administration Riverside Avenue, Rensselaer, New
(DEA), 28 CFR 0.100(b). Authority to York 12144 applied to be registered as
DATES: Registered bulk manufacturers of exercise all necessary functions with a bulk manufacturer of the following
the affected basic classes, and respect to the promulgation and basic classes of controlled substances:
Controlled substance Drug code Schedule
Marihuana ........................................................................................................................................................................ 7360 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
Amphetamine ................................................................................................................................................................... 1100 II
Lisdexamfetamine ............................................................................................................................................................ 1205 II
Methylphenidate .............................................................................................................................................................. 1724 II
Pentobarbital .................................................................................................................................................................... 2270 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II
Codeine ........................................................................................................................................................................... 9050 II
Oxycodone ....................................................................................................................................................................... 9143 II
Hydromorphone ............................................................................................................................................................... 9150 II
Hydrocodone ................................................................................................................................................................... 9193 II
Meperidine ....................................................................................................................................................................... 9230 II
Morphine .......................................................................................................................................................................... 9300 II
Fentanyl ........................................................................................................................................................................... 9801 II
The company plans to manufacture DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: The
bulk controlled substances for use in companies listed below applied to be
product development and for Drug Enforcement Administration registered as manufacturers of various
distribution to its customers. [Docket No. DEA–392] basic classes of controlled substances.
In reference to drug codes 7360 Information on previously published
(marihuana) and 7370 (THC), the Bulk Manufacturer of Controlled notices is listed in the table below. No
company plans to bulk manufacture Substances Registration comments or objections were submitted
these drugs as synthetics. No other for these notices.
activities for these drug codes are ACTION: Notice of registration.
authorized for this registration.
SUMMARY: Registrants listed below have
Dated: July 19, 2017. applied for and been granted
Demetra Ashley, registration by the Drug Enforcement
Acting Assistant Administrator. Administration (DEA) as bulk
[FR Doc. 2017–15688 Filed 7–25–17; 8:45 am] manufacturers of various classes of
BILLING CODE 4410–09–P controlled substances.
Company FR docket Published
Cedarburg Pharmaceuticals ...................................................................................... 82 FR 19083 ........................................... April 25, 2017.
Siegfried USA, LLC ................................................................................................... 82 FR 19084 ........................................... April 25, 2017.
Sigma Aldrich Research Biochemicals, Inc .............................................................. 82 FR 19085 ........................................... April 25, 2017.
mstockstill on DSK30JT082PROD with NOTICES
The DEA has considered the factors in treaties, conventions, or protocols in company’s compliance with state and
21 U.S.C. 823(a) and determined that effect on May 1, 1971. The DEA local laws, and reviewing each
the registration of these registrants to investigated each of the company’s company’s background and history.
manufacture the applicable basic classes maintenance of effective controls Therefore, pursuant to 21 U.S.C.
of controlled substances is consistent against diversion by inspecting and 823(a), and in accordance with 21 CFR
with the public interest and with United testing each company’s physical 1301.33, the DEA has granted a
States obligations under international security systems, verifying each
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Document Created: 2017-07-26 01:29:44
Document Modified: 2017-07-26 01:29:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| Dates | Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before August 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 25, 2017. | |
| FR Citation | 82 FR 34694 |
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